The webinar content spans from the main definitions of frequently used terms to the real-life examples of Observational Research deployment at various stages of the drug life-cycle. It will provide the participants with basic knowledge on ‘hows’, ‘whens’ and, perhaps most importantly, ‘whys’ of this particular kind of evidence generation.

Speakers: Gabriele Musso, MediNeos Clinical Project Portfolio Manager

Graduated in Sociology and Social Research from University of Eastern Piedmont after studying abroad at Jagiellonian University in Kraków (Poland). Gabriele started his work experience in MediNeos as Study Manager. Since then, he has gained experience in both international and local project management of observational studies, clinical site management and pharmacovigilance, national laws and regulations applicable to observational research.

EU has introduced rules on data protection with the objective of harmonizing the various local regulations and to facilitate the free movement of data, in balance with the protection of the rights and dignity of individuals; first notes relating to this balance in the clinical research. In this workshop, it will be highlighted what has been the impact of GDPR for the observational research

Speaker: F. Preite, lawyer

She obtained a law degree in 1994 and she is been practicing since 1997. She dedicates most of her work activities to business consultancy especially in the field of clinical research with particular attention to the Privacy legislation in epidemiological studies and management of clinical databases. On these issues she has published several contributions including some articles for the Italian Society of Medical Statistics and Clinical Epidemiology (SISMEC).

For more information and registration: training@medineos.com

The workshop that will be held in Rome from 2pm to 5.30pm is free and reserved to MediNeos clients

The aim of this webinar is to provide a methodologic overview of the peculiarities and opportunities of observational studies on rare diseases.

As the real-world research on rare diseases is persistently growing in demand, a general understanding of appropriate observational methods is recommended in order to approach this interesting and challenging epidemiologic area.

He has a scientific background in biotech and rare disease with a strong experience in observational research. He is working in MediNeos since 2009 and currently covering the Clinical Project Portfolio Manager position

The webinar - that will be held at 3pm (CET) - is free and reserved to MediNeos clients

The aim of this webinar is to share an introduction about what site management means in Observational Studies. We will define what site management is, because some overlaps in definitions are still quite common.Then we will illustrate the typical site management tools, with specific regard to the study dashboard recommended for study management. In the second half of the webinar we will describe the most commonly used indicators in site management with specific examples.

Speaker: Alessandra Ori, MediNeos Clinical operations Manager

She started her working experience with important medical device manufacturers and since 2005 Alessandra has been working in MediNeos. Throughout the years she has built competence in clinical epidemiology, Clinical Site Management GCP applications, national and international regulations applied to clinical research.

The webinar - that will be held at 3pm (CET) - is free and reserved to MediNeos clients

The webinar will provide an overview of the regulatory framework applicable to the conduction of an observational PASS study. Attendees will be given indications on mandatory and recommended provisions on the design of an observational PASS study.

Speaker: Sara Montanari, MediNeos Quality Assurance Manager

She has competencies in genetics, clinical epidemiology, GCP, Patients Reported Outcomes, computer system validation, pharmacovigilance, quality assurance and quality compliance processes, and in laws and regulations applicable to the conduction of clinical studies.

The webinar - that will be held at 3pm (CET) - is free and reserved to MediNeos clients

The workshop will be focused on main characteristics of Patient registries, with particular attention on some methodological aspects and main advantages. Some examples will also be provided and discussed.

Speaker: Christian Amici, MediNeos Clinical Project Portfolio Manager

After graduating in Pharmaceutical Biotechnology, he obtained a master’s degree in International Health Care Management, Economics and Policy at Bocconi University (Milan). He began his work experience in MediNeos in 2009 as Clinical Research Associate and later as a Study Designer. Since 2014 he has covered the role of Clinical Project Portfolio. Christian has a consolidated experience in: observational research, international and local project management and account, public speech and epidemiology

To register write to training@medineos.com

The workshop that will be held in Rome from 2pm to 5.30pm is free and reserved to MediNeos clients

While the wide-ranging subject of quality is perfectly well regulated in clinical trials, it still remains foggy in observational research because of some legal gaps that lead to frequent difficulties/doubts for specialized operators. During this webinar we will explore different views on this subject, bringing some specific situations related to Real World Data research and giving much room for discussion from the audience.

Speaker: Sara Montanari, MediNeos Quality Assurance Manager

She has competencies in genetics, clinical epidemiology, GCP, Patients Reported Outcomes, computer system validation, pharmacovigilance, quality assurance and quality compliance processes, and in laws and regulations applicable to the conduction of clinical studies.

The webinar - that will be held at 3pm (CET) - is free and reserved to MediNeos clients

In real world observational research, two basic components of any study are exposure and outcome. In absence of randomization, bias occurs when a measure of association between exposure and outcome is systematically wrong. Selection bias, misclassification and confounding are typical problems that must be faced by the researcher so that a causal unbiased association between exposure and outcome is estimated. Knowing and understanding these feared demons is the first step for fighting them, armed with the powerful weapons of study design and statistical analysis.

Graduated in Biomolecular and Cellular Sciences at the University of Ferrara. He has skills in designing observational studies, study protocol writing, planning and implementation of statistical analysis in SAS, statistical reports and clinical reports, publication of results, and evaluation of psychometric properties of questionnaires. He is also lecturer in webinars and training courses on statistical and epidemiological methods.

The webinar - that will be held at 3pm (CET) - is free and reserved to MediNeos clients

Starting with a few common definitions, the webinar will give insights about how to plan and manage patient registries from both a methodological and a statistical point of view. We will also describe types and benefits of patient registries and studies derived from them.

Speaker: Christian Amici, MediNeos Clinical Project Portfolio Manager

After graduating in Pharmaceutical Biotechnology, he obtained a master’s degree in International Health Care Management, Economics and Policy at Bocconi University (Milan). He began his work experience in MediNeos in 2009 as Clinical Research Associate and later as a Study Designer. Since 2014 he has covered the role of Clinical Project Portfolio. Christian has a consolidated experience in: observational research, international and local project management and account, public speech and epidemiology

The webinar - that will be held at 3pm (CET) - is free and reserved to MediNeos clients

The webinar will present guidelines for best practices in publishing and presenting scientific results, with a special focus on results from observational studies. It will cover the widely cited STROBE and CONSORT statements.

Speaker: Sara Rizzoli, Medineos Senior Biostatistician

She obtained a MS degree in Statistics and a Master in Communication and Information Technology (University of Bologna). In MediNeos she is responsible for writing study protocols (statistical analysis and sample size paragraphs), designing and validating the case report forms, for data analysis (statistical analysis plans, statistical and clinical study reports). She is author of scientific publications on international journals and of scientific communications both at national and international congresses.

The webinar - that will be held at 3pm (CET) - is free and reserved to MediNeos clients